Defined Organism Substance - Monascus

NHPID name:

Monascus

Reference:

CHIN_MED_PHARM_2004

Proper name(s):

Red yeast rice

Common name(s):

Category:

Approved Herbal Substance Name

Monograph(s):

Traditional Chinese Medicine Ingredients

Schedule 1:

Extract

Source material(s):

Monascus purpureus ( Parts: Whole )
Oryza sativa ( Parts: Seed )

Preparations:

Decoction , Decoction concentrate , Dry , Extract dry , Powdered

Additional details

Detail:

This medicinal ingredient is specifically for use in traditional Chinese medicine products. Oryza sativa - Seed, as well as Monascus purpureus - Whole, must be selected as source information in the web PLA form.

Roles

Medicinal

Rationale:

Classified as an NHP under Schedule 1, item 2 (an extract) of the Natural Health Products Regulations.

Reference: NNHPD

Restrictions:

Daily Dose

Upper limit:

1.0

Units:

Milligrams/24 hour

Route Of administration:

Oral

Detail:

The Prescription Drug List exemption for Lovastatin, when sold for human use in oral dosage form that provides 1 milligram or less per daily dose, allows red yeast rice products containing only trace amounts of Lovastatin to be marketed as natural health products in Canada.

Reference:

PDL